Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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A CMC Professional At Sanofi Focuses On Collaborations (And The Right Questions)

Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

GUEST COLUMNISTS

March 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.
Mastering Biotech's Insourcing/Outsourcing Trade-Offs
Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.
From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
Quantifying Single-Use Waste Produced During mAb Manufacture
Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
The Systems And Choreography Needed For Grade B ATMP Material Transfer
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

PHARMA OUTSOURCING WHITE PAPERS

A Comprehensive Solution For Adventitious Agent Testing
Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.

A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter
Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.
Essential Strategies For Effective Viral Clearance Studies In Biologics Manufacturing
Strengthen your viral safety strategy by applying science- and risk-based approaches to viral clearance planning, ensuring robust data, regulatory compliance, and patient protection.
Antibody-Drug Conjugates – Catalysts For Chemistry
Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.
The Relevance Of Polymorph Screening In The Pharmaceutical Industry
Polymorph screening identifies different solid forms of active pharmaceutical ingredients, optimizing drug stability, solubility, and manufacturability. This process ensures quality, regulatory compliance, and intellectual property protection in pharmaceutical development.